Coffee Consumption and NASH in the French Population. (COCANASH)

January 27, 2021 updated by: Dr Hugues Blondon, Versailles Hospital
The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Béziers, France, 34500
        • Centre Hospitalier de Beziers
      • Chambéry, France, 73011
        • Centre Hospitalier Metropole Savoie
      • Corbeil-Essonnes, France, 91100
        • Centre Hospitalier Sud Francilien
      • Creil, France, 60100
        • Groupe Hospitalier Public Sud Oise
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Creteil
      • Gonesse, France, 95500
        • Centre Hospitalier de Gonesse
      • Hyères, France, 83400
        • Centre Hospitalier de Hyères
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Departemental Vendee
      • Lorient, France, 56322
        • Centre Hospitalier de Bretagne Sud
      • Melun, France, 77011
        • Hôpital de Melun
      • Metz-Tessy, France, 74370
        • Centre Hospitalier Annecy Genevois
      • Montélimar, France, 26200
        • Centre Hospitalier Montelimar
      • Paris, France, 75012
        • Hôpital de Diaconesses
      • Perpignan, France, 66000
        • Centre Hospitalier de Perpignan
      • Saint-Denis, France, 93200
        • Centre Hospitalier de Saint Denis
      • Sens, France, 89100
        • Centre Hospitalier de Sens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-Alcoholic Steatohepatitis

Description

Inclusion Criteria:

Any newly diagnosed case of NASH histologically proven graded according to SAF criteria

Or Metabolic syndrome defined by the IDF 2005 criteria:

  • waist size> 94cm (men) or> 80cm (women)

  • and the presence of at least two of the following criteria:

    • blood pressure: Systolic ≥ 130mmHg OR diastolic ≥ 85 mmHg OR antihypertensive treatment
    • Triglycerides ≥ 1.5g / L or lipid-lowering therapy
    • HDL cholesterol <0.4 g / L (men) or <0.5 g / L (women) or lipid-lowering therapy
    • fasting blood glucose:> 1 g / L or type 2 diabetes AND Hepatic steatosis diagnosed on liver imaging And liver fibrosis (diagnosed with a FibroScan> 6 KPa)

Exclusion Criteria:

  • Age <18 years
  • Viral hepatitis and other chronic liver diseases
  • Alcohol consumption> 20g / day for women, 30g / day for men
  • Liver biopsy or FibroScan dating more than 6 months before inclusion.
  • History of bariatric surgery
  • Serious psychiatric pathology (psychosis, dementia, severe depression) and patients under legal protection (tutelage, guardianship)
  • Solid cancer or progressive hematology or <2 years (except basal cell carcinoma or localized squamous cell carcinoma)
  • Severe and terminal chronic renal insufficiency (estimated GFR <30mL / min)
  • Recent myocardial infarction <6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare coffee caffeine consumption in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the correlation between the degree of hepatic fibrosis assessed by elastometry (FibroScan) or the histological stage and the caffeine consumption from coffee in univariate analysis and after adjustment for potential confounding factors.
Time Frame: Day 0
Day 0
Comparison of the percentage of regular coffee drinkers in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.
Time Frame: Day 0
Day 0
Comparison of total caffeine consumption from all types of drinks in patients with NASH with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Investigators

  • Principal Investigator: Hugues BLONDON, Department head, Versailles Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

November 17, 2020

Study Completion (Actual)

November 17, 2020

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16/17_COCANASH
  • 2016-A01872-49 (Registry Identifier: ID RBC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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